Ignite Creation Date:
2025-12-25 @ 2:35 AM
Ignite Modification Date:
2026-01-06 @ 5:42 AM
Study NCT ID:
NCT06532734
Status:
RECRUITING
Last Update Posted:
2025-12-10
First Post:
2024-07-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Barrett's Esophagitis in Anorexia Nervosa Binge/Purge Subtype
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001471', 'term': 'Barrett Esophagus'}, {'id': 'D000856', 'term': 'Anorexia Nervosa'}, {'id': 'D002032', 'term': 'Bulimia'}, {'id': 'D000079562', 'term': 'Rumination Syndrome'}, {'id': 'D014839', 'term': 'Vomiting'}, {'id': 'D001068', 'term': 'Feeding and Eating Disorders'}, {'id': 'C562730', 'term': 'Adenocarcinoma Of Esophagus'}], 'ancestors': [{'id': 'D011230', 'term': 'Precancerous Conditions'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D006963', 'term': 'Hyperphagia'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 25}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-11-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-03', 'studyFirstSubmitDate': '2024-07-29', 'studyFirstSubmitQcDate': '2024-07-31', 'lastUpdatePostDateStruct': {'date': '2025-12-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-08-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients positive for BE', 'timeFrame': '12 months', 'description': 'Individuals with severe forms of eating disorders with purging and ruminating behaviors not meeting a current screening guidelines for BE will test positive for BE'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Barrett Esophagus', 'Anorexia Nervosa, Binge Eating/Purging Type', 'Rumination', 'Vomiting', 'Eating Disorders', 'Esophageal Adenocarcinoma']}, 'descriptionModule': {'briefSummary': "To better define the presence of Barrett's esophagus (BE) via non-endoscopic testing in an eating disorder cohort with purging (vomiting/rumination) behaviors", 'detailedDescription': "A prospective cohort study to assess the presence of BE in those with purging behaviors from their eating disorders has not been completed. There are multiple case reports describing a younger population not meeting typical screening guidelines whom developed this condition. To better define the presence of Barrett's esophagus (BE) via non-endoscopic testing in an eating disorder cohort with purging (vomiting/rumination) behaviors. Individuals with severe forms of eating disorders with purging and ruminating behaviors not meeting the current screening guidelines for BE will still test positive for BE."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'ACUTE patients with a confirmed dx of AN-BP, with a purging history of \\>5 year, with a frequency of purging of at least once a day.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients diagnosed with an eating disorder diagnosis that includes purging history\n* Ages 18-65\n* Purging history =\\>5 years\n* Purging or rumination at a minimum of once daily upon admission.\n* Admission to the ACUTE Center for Eating Disorders and Severe Malnutrition\n\nExclusion Criteria:\n\n* Any eating disorder diagnosis that does not include purging behaviors\n* Ages under 18 and over 65\n* Patients who otherwise meet the current ACG screening guidelines (chronic GERD and 3 or more risk factors for Barrett's mentioned in the Background)\n* Received mandated care at time of enrollment\n* Inability to consent to participate in the research"}, 'identificationModule': {'nctId': 'NCT06532734', 'briefTitle': "Barrett's Esophagitis in Anorexia Nervosa Binge/Purge Subtype", 'organization': {'class': 'OTHER', 'fullName': 'Denver Health and Hospital Authority'}, 'officialTitle': "Presence of Barrett's Esophagitis in a Cohort of People With Eating Disorders Who Engage in Purging Behaviors: A Pilot Study", 'orgStudyIdInfo': {'id': '24-0349'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'AN-BP', 'description': 'individuals with a dx of AN-BP, with a \\>5-year history of purging, with a frequency of at least once a day.', 'interventionNames': ['Device: EsoGuard']}], 'interventions': [{'name': 'EsoGuard', 'type': 'DEVICE', 'description': "device used to collect esophageal cell samples to test for the presence of abnormal cells which may indicate a dx of Barrett's esophagitis.", 'armGroupLabels': ['AN-BP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80204', 'city': 'Denver', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Marina J Foster, BA', 'role': 'CONTACT', 'email': 'marina.foster@dhha.org', 'phone': '303-602-1913'}, {'name': 'Alllison Nitsch, MD', 'role': 'CONTACT', 'email': 'dennis.gibson@dhha.org', 'phone': '303-602-5067'}], 'facility': 'ACUTE Center for Eating Disorders and Severe Malnutrition', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '80204', 'city': 'Denver', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Marina Foster', 'role': 'CONTACT', 'email': 'marina.foster@dhha.org', 'phone': '3036021913'}], 'facility': 'Denver Health and Hospital Authority', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '80204', 'city': 'Denver', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Marina J Foster, BA', 'role': 'CONTACT', 'email': 'marina.foster@dhha.org', 'phone': '303-602-1913'}, {'name': 'Alllison Nitsch, MD', 'role': 'CONTACT', 'email': 'Allison.nitsch@dhha.org', 'phone': '303-602-7701'}, {'name': 'Allison Nitsch, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Denver Health and Hospital Authority', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}], 'centralContacts': [{'name': 'Marina J Foster, BA', 'role': 'CONTACT', 'email': 'marina.foster@dhha.org', 'phone': '303-602-1913'}, {'name': 'Allison Nitsch, MD', 'role': 'CONTACT', 'email': 'Allison.nitsch@dhha.org', 'phone': '303-602-5067'}], 'overallOfficials': [{'name': 'Allison Nitsch, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Denver Health and Hospital Authority'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Denver Health and Hospital Authority', 'class': 'OTHER'}, 'collaborators': [{'name': 'Lucid Diagnostics, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lead Hospitalist', 'investigatorFullName': 'Allison Nitsch', 'investigatorAffiliation': 'Denver Health and Hospital Authority'}}}}